Thursday, April 30, 2009
Friday, April 24, 2009
The CIA on June 26, 2007 declassified secret documents that revealed "the Agency had relations with commercial drug manufacturers, whereby they passed on drugs rejected because of unfavorable side effects."
Killer Drug is a thriller about one such drug company, which develops a biological weapon and uses murder to achieve its objectives. It is also a drama about just how far corporate executives may be willing to go . . .
Go to Amazon for your copy or read the first six chapters free!
Thursday, April 23, 2009
The CIA on June 26, 2007 declassified secret documents that revealed "the Agency had relations with commercial drug manufacturers, whereby they passed on drugs rejected because of unfavorable side effects."
Killer Drug is a thriller about one such drug company, which develops a biological weapon and uses murder to achieve its objectives. It is also a drama about just how far corporate executives may be willing to go . . .
Go to Amazon for your copy or read the first six chapters free!
Tuesday, April 21, 2009
By Joel Stein
I knew having a child would force me to examine my life, but I didn't expect to have to start with my penis. When my wife and I found out we were having a boy, everyone asked if we were going to circumcise him. All I knew was that circumcision is something the U.S. does and Europe doesn't and is therefore awesome. Our penises are clean and sleek and new like Frank Gehry skyscrapers, while theirs are crumbling, ancient edifices inhabited by fat old men in hats.
But when I thought about it, there was something disturbing about the fact that someone had chopped off part of my penis — a part that not only had nerve endings and a protective function but also could have made me look bigger. When I presented these arguments to my lovely wife Cassandra, she told me to shut up. Her argument was largely based on aesthetics and involved a lot of detailed talk about the surprising number of men she had dated. It's hard to win a debate when you're busy covering your ears and singing to yourself. (Read about Joel Stein's quest to name his baby.)
I argued that our son would not feel embarrassed either way, since compared with American babies in the 1960s, when 90% got snipped, about half of newborns are now deforeskinned — and only about 30% of California infants. I went on Facebook to ask if being made fun of in the locker room was apocryphal. What I learned is that even Facebook users disapprove of making parental decisions on Facebook. And kids probably don't make fun of one another, since the Centers for Disease Control and Prevention found that only 69% of circumcised and 65% of uncircumcised adolescents know which one they are. Also, you don't need to be Don Rickles to respond to someone's mockery of your foreskin with a casual "Dude, why are you staring at my penis?"
All I knew was that this is clearly not a decision I should be making for another human being. What school he attends, what he eats, which bouncy seat he should bounce in — sure. Whether to alter your genitals for aesthetic reasons is a question meant for your mid-20s at Burning Man.
Still, I knew this decision was going to be made now or never, so I started asking every medical professional, woman and gay man what kind of penis they preferred, which, to my shock, got me a lot of dinner invitations. Though there seemed to be a slight aesthetic preference for not wearing a hat and a slight functional preference for keeping one on, no one had a really good argument for giving your baby plastic surgery. A pediatrician told me the sole reason he circumcised his son was so that the kid looked like him. If my son looks at my penis and the biggest difference he notices is foreskin, I have far more serious problems. Plus, if I wanted my son to look like me, I wouldn't have worked so hard to marry someone better-looking than I am.
It turns out, though, that there's an enormous group of people who would argue passionately for my son's foreskin. Francis Crick and Jonas Salk were among the Nobel laureates who signed a petition to the World Court to end circumcision. The last week of March was Genital Integrity Awareness Week, which included a march from the White House to the Capitol, which, while not far in miles, is an eternity when measured in baby foreskins. This cause is so real, it has its own ribbon. There's even a group called Jews Against Circumcision, made up almost exclusively of Jews whose parents no longer talk to them. (Read "The Great Uncircumcision Debate.")
The antisnipping crusaders argue that the ancient Greeks rejected this violent tribal custom of the Jews and Muslims; hardly anyone practices it anymore besides those groups and Americans. They argue that the Jews created it as a way either to exclude women from their club or to ritualize the sacrifice of the firstborn male. They say it was brought to the U.S. in Victorian times only as a means of reducing masturbation by limiting sensation, in what has to be the biggest failed medical experiment in history.
Cassandra would not hear any of this. She felt strongly that our son should feel Jewish and that when she bathes him, she shouldn't have to touch his penis too much. And then last month, a study from Africa showed that circumcision greatly reduces the chances of catching a sexually transmitted disease. And I had lost my argument.
So in a few weeks, I'm going to buy some bagels, call a mohel who is also a pediatric surgeon and believes in local anesthetic, and do something that I'm pretty sure is wrong. I have a horrible feeling that all of parenthood is like this.
2. Page Yourself Over The Intercom. Don't Disguise Your Voice.
3. Every Time Someone Asks You To Do Something, Ask If They Want Fries with that.
4. Put Your Garbage Can On Your Desk And Label It "In."
5. Put Decaf In The Coffee Maker For 3 Weeks. Once Everyone Has Gotten Over Their Caffeine Addictions, Switch To Espresso.
6. In The Memo Field Of All Your Checks, Write "For Sexual Favors"
7. Finish All Your Sentences With "In Accordance With The Prophecy."
8. Don't Use Any Punctuation
9. As Often As Possible, Skip Rather Than Walk.
10. Ask People What Sex They Are. Laugh Hysterically After They Answer.
11. Specify That Your Drive-through Order Is "To Go."
12. Sing Along At The Opera.
13. Go To A Poetry Recital And Ask Why The Poems Don't Rhyme
14. Put Mosquito Netting Around Your Work Area And Play Tropical Sounds All Day.
15. Five Days In Advance, Tell Your Friends You Can't Attend Their Party because You're Not In The Mood.
16. Have Your Co-workers Address You By Your Wrestling Name, Rock Hard.
17. When The Money Comes Out The ATM, Scream "I Won! I Won!"
18. When Leaving The Zoo, Start Running Towards The Parking Lot, Yelling
"Run For Your Lives, They're Loose!!"
19. Tell Your Children Over Dinner. "Due To The Economy, We Are Going To Have To Let One Of You Go."
And The Final Way To Keep A Healthy Level Of Insanity.......
20. Copy this and Send an E-mail To Someone To Make Them Smile..
It's Called Therapy...
Monday, April 20, 2009
Saturday, April 18, 2009
Tuesday, April 14, 2009
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Friday, April 10, 2009
A film director with great credentials in Los Angeles recently signed on the dotted line to work on a television series based on my book "The Whistleblower."
Things are getting interesting.
This is his story, edited for length and to preserve confidentiality:
"I just finished reading your book and it is amazing to see many parallels to my recent experience. Although not a senior VP, I was a -----------. My territory was ----------- and I really enjoyed my job and the company. In the fall of 2004, I encountered a sales rep in a hospital parking lot and started chatting. Our conversation quickly turned to a common e-mail sent out by Pfizer to 'retain all documents related to Bextra/Celebrex.'
In the same week, a group of individuals from our geography also received notice to turn in our laptops so they could basically 'harvest' information from our harddrives (my VP informed me not to worry about that kind of request, that it happens all the time).
The rep that I was speaking with said that he received both messages and that he had spent the weekend "cleaning" his laptop as well as helping his less senior colleagues clean theirs, as well. This, of course, set off a big red flag in the back of my mind--but I didn't say anything to the rep.
I just took it in and went about my business. I had important information of 'illegal' activities going on in our territory--specifically, deleting <> files from laptops after being told very clearly to 'retain'; however, I stewed for a couple of days about who I should report this to. At the time, Pfizer did not communicate a clear direction to report these deeds.
Thinking that I would do the right thing, I informed my manager, as well as the DM and Regional manager of the rep that I spoke with. I quickly learned that speaking with the DM was a big mistake--by the tone of our conversation, it became clear to me that the reps were ordered to take these actions.
Anyway, long story longer: I was suddenly asked to meet with Pfizer attorneys and informed that I was being questioned as an employeed and that I didn't need my own counsel. I'm a very trusting person, and still believing that I was doing the right thing, complied with all of their requests. After meeting with a big NY law firm and answering their questions, I was asked to come back in a second time to meet with a Washington, DC law firm.
I didn't hear any follow up from these meetings. I answered all the questions truthfully about the reps, my interactions, etc. They asked a lot of questions about activities that I was not aware of, and of course, unable to comment on.
After that, I didn't hear any follow-up or feedback for giving this 'cooperation'--Until early in 2005.
I was contacted by the Pfizer attorneys and informed that the Federal Prosecuter in Boston wanted me to go in front of a grand jury. I was extremely nervous about the whole idea. But, rest assured, the Pfizer attorneys, Covington and Burling, made sure that I was confortable.
So much so, that they asked me back twice and had a couple of conference calls to 'coach' me on how to answer the questions. Making sure that I kept to very succinct yes/no answers and did not go into any more detail than I was asked to.
Being naive, I agreed to let Pfizer provide me with my legal counsel (apparently, the Pfizer lawyers could not represent me, but they informed me that my lawer would be -----------and that he would contact me--highly discouraging me, once again, to get my own representation).
At that time, Pfizer was going through another re-organization. In the Spring of 2005, I was told that my territory no longer existed and that I was 'displaced' from my job--my counterpart, who shared the same territory, however, got to keep her position.
I still had a position in Pfizer, but I would have to relocate (----------- was one lovely locale offered to me). I had until ----------- to find another place in Pfizer or take a severence package. In the meantime, my workload decreased and I was actively interviewing for other positions - with the blessing (but, of course not a reference) from my manager.
I had to go to Boston one day early for, what my adopted-Attorney called a 'prep' meeting. When I entered the room, there were about seven people around the table representing FBI, HHS, GAO, and of course the Fed prosecuter and assistants.
I was taken by surprise by this--and by the questioning, felt like I was the one being investigated. The next day, I was in front of the grand jury for maybe 30 minutes tops. I have to give the prosecutor credit, she was well-prepared and asked me very specific questions to tell the story that she wanted to in front of that audience.
Anyway, I ultimately left Pfizer, and after bouncing around a little, finally landed in a great job with a small company. I'm very happy to have that experience behind me.
I hope you find resolution with your ordeal--and thanks for writing the book; it helps stick up for the smaller, more trusting people like myself that believe in a company so much that they get led into this trap."
Wednesday, April 08, 2009
I USA betraktas de som cowboys, som gör allt för att sälja
Mirakelpillret Seroquel drar in ofantliga 36 miljarder kronor om året till Astra Zeneca.
25 miljoner människor, varav flera tusen i Sverige, har fått medicinen som lindrar psykisk ohälsa.
Men bakom den ekonomiska succén växer skandalerna: mörkade biverkningar, illegal marknadsföring och självmord under studierna.
Rättssalar kommer nu att fyllas och företrädarna för Astra Zeneca kallas "cowboys utan moral".
I en lägenhet på Södermalm i Stockholm täcker en 30-årig kvinna över hallspegeln med ett stort lakan. Hon orkar inte se sig själv. För en månad sedan började hon ta medicinen Seroquel. Depressionen börjar nu lätta, sömnen förbättras, men vikten ökar. Att medicinen gör patienterna feta har Astra Zeneca känt till sedan introduktionen 1997. I snitt går patienterna upp fem kilo om året och risken för diabetes ökar. Biverkningarna avslöjades i "Studie 15", som omedelbart hemligstämplades av Astra Zeneca. Varken läkarna eller patienterna skulle få veta sanningen.
Nu står det klart vad som hände. Advokatbyrån Blizzard, McCarthy & Nabers lyckades nyligen i en rättegång i Orlando få Astra Zeneca att offentliggöra dokumenten.
New York Times kunde dessutom publicera Astra Zenecas interna e-post från 1997. Richard Lawrence, en av cheferna, hyllade den anställda Lisa Arventis och skrev:
"Lisa har gjort ett fantastiskt jobb med mörkläggningen!".
Drygt 15000 amerikaner vill nu ha skadestånd av Astra Zeneca. Efter medicinering med Seroquel har de drabbats av både fetma och diabetes, kanske även hjärtsjukdomar.
Några snabba klick på nätet räcker för att hitta en advokat som gratis åtar sig deras fall, ett bevis för att juristerna redan identifierat Astra Zeneca som en lämplig kassako.
Hittills har medicinen Seroquel orsakat över 9000 stämningar mot Astra Zeneca
Svensken Peter Rost, tidigare vice vd för läkemedelsjätten Pfizer, är numera expertvittne i rättegångar mot läkemedelsbolagen. Han gillar det amerikanska systemet.
- Skadestånden i Sverige är ju ett skämt. Om läkaren sågar av fel ben får patienten kanske 20000 kronor. Det ska förstås kosta att göra fel, säger han.
Astra Zeneca riskerar inte bara att få betala skadestånd till patienterna.
Även den amerikanska staten känner sig lurad av den svenskbrittiska läkemedelsjätten. Anklagelserna handlar om illegal marknadsföring.
- Rättsprocesserna har precis dragit i gång i USA och vi kan inte kommentera, säger Anne-Charlotte Knutsson, informationsdirektör på Astra Zeneca.
Om Astra Zeneca fälls blir beloppen enorma, antagligen i miljardklassen. Läkemedelsbolaget Eli Lilly dömdes nyligen till böter på sammanlagt 1,4 miljarder dollar för marknadsföringen av Zyprexa, som tillhör samma läkemedelsgrupp som Seroquel.
- Bolaget får böta tre gånger mer än vad de har tjänat på marknadsföringen. Ett par hundra miljoner dollar är inte ovanligt, men i Sverige blir det bara pinsamma hundratusen kronor till Lif (branschföreningen), säger Peter Rost.
Seroquel är i dag godkänd för behandling av schizofreni och bipolär sjukdom. Hittills har 25 miljoner patienter världen över fått medicinen. Astra Zeneca kan inte ge någon exakt siffra, men beräknar att "ett par tusen svenskar" får Seroquel.
Många patienter har blivit hjälpta av medicinen, kanske fått livet åter. Men i stämningarna anklagas Astra Zeneca för att ha övertygat läkare att skriva ut medicinen mot en rad sjukdomar, från sömnproblem till ångest och depressioner. Myndigheterna har hittills inte kunnat slå fast att medicinen är verksam mot dessa sjukdomar. Astra Zeneca kämpar för att Seroquel ska uppfylla kraven.
- Vi har lämnat in ansökningar för att få den godkänd för egentlig depression och generaliserad ångest, säger Anne-Charlotte Knutsson.
I Sverige beräknas fem procent av befolkningen lida av depression. I USA ökar målgruppen för medicinen med 20 miljoner personer, om medicinen godkänns för de nya indikationerna. Men det amerikanska läkemedelsverket, FDA, tvekar inför godkännandet. Listan över biverkningar är lång.
- Seroquel är ingen tandlös medicin. Den ingår i en grupp läkemedel med stor effekt men kan också ge betydande biverkningar, säger psykiatern Bo Bergman på Läkemedelsverket.
Miljardvinsterna från Seroquel, som är bolagets mest sålda läkemedel efter magmedicinen Nexium, har fått Astra Zeneca att bli Stockholmsbörsens lyckopiller. Aktien har hittills i år gått upp med 13 procent. Ett hot mot de framtida vinsterna är att patentet går ut under 2011. Då blir det fritt fram att tillverka kopior. Astra Zeneca har stämt flera tillverkare för att i förtid ha tillverkat kopior.
Läkemedelsföretag lanserar ofta nya beredningsformer för att förlänga sina patent. Inte minst har Astra Zeneca tillämpat den strategin. Den nya formuleringen heter Seroquel SR, och skyddas av patent fram till 2017.
- Den är långtidsverkande och hjälper många patienter som kanske inte kommer ihåg att ta medicinen tillräckligt ofta, säger Anne-Charlotte Knutsson.
Så sent som för två veckor sedan briserade ytterligare en skandal kring Seroquel. Ekot avslöjade experiment med medicinen under 2005 och 2006. För att ta reda på om Seroquel förebygger återfall i schizofreni rekryterades patienter från 26 forskningscentra i Ryssland, Ukraina, Polen, Bulgarien och Indien. Hälften av patienterna fick Seroquel, hälften lämnades utan behandling. Konsekvensen blev att 36 patienter återinsjuknade, en av dem tog sitt liv. Patienten hade fått placebo och stod utan medicinering.
Astra Zeneca förnekar att självmordet går att koppla till studien och betonar att man följt alla regler i testländerna.
Christian Munthe, expert på medicinsk etik vid Göteborgs universitet, tycker inte att den förklaringen håller.
- Det här är inte en juridisk formsak. Bolaget måste göra egna överväganden över vad som är etiskt försvarbart. Ingen tvingade dem att göra studier i dessa länder.
Han tycker att läkare har ett moraliskt ansvar för vilka mediciner de skriver ut. En metod är att bojkotta det läkemedelsbolag som skriver ut mediciner framtagna med oetiska metoder.
- Nu kanske det inte finns något alternativ till Seroquel för patienten, men Astra tillverkar ju många mediciner.
Eva Nilsson Bågenholm, ordförande i Läkarförbundet, tycker att idén med en bojkott är god men svår att genomföra.
- Om ett bolag undviks måste en medicin från ett annat bolag väljas, och vem känner till alla omständigheter kring den medicinen? Läkarna hinner inte hålla koll, säger hon.
Kraftiga böter kan därför vara metoden som får läkemedelsbolagen att följa reglerna.
I amerikanska medier får skandalerna kring Seroquel stor uppmärksamhet. I Sverige är det däremot ganska tyst. Nils Bergeå, projektledare på Dagens Medicin, tror att det finns två förklaringar.
- I USA har Seroquel fått ett mycket större genomslag än i Sverige. Dessutom har de ett annat sjukvårdssystem som leder till stämningar.
Bilden av Astra Zeneca i USA blir därmed en annan än den i Sverige.
- I USA betraktas Astra Zeneca som cowboys, de gör allt för att sälja sina mediciner. I Sverige är Astra Zeneca det välartade företaget i Södertälje, säger Peter Rost.
Om kvinnan på Södermalm får oönskade biverkningar av Seroquel kommer inga slipade advokater att erbjuda sina tjänster utan kostnad. Här finns inga stora pengar att tjäna på läkemedelsskandaler. Hittills är hon ändå ganska nöjd med Seroquel.
Av Lennart Kriisa email@example.com
Tuesday, April 07, 2009
Then there was MARY HOLLOWAY, a Regional Sales Manager at Pfizer, who plead guilty to a one count Information charging her with distribution of a misbranded drug. She faces up to six months’ imprisonment, to be followed by not more than 3 years of supervised release and a maximum fine of $100,000 or twice the amount of gross loss or gross gain.
Now the guessing game is on inside Pfizer about which executive is next.
Mary Holloway, according to messages on CafePharma reported to a Pfizer VP Sales, who according to other messages on CafePharma very, very recently suddenly left Pfizer.
And other people who were responsible for the Bextra launch apparently also recently disappeared from Pfizer. According to yet more messages on CafePharma.
Bodnar, who was a senior vice president of strategy and a member of Bristol's executive committee, was indicted a year ago for misleading statements to the U.S. Federal Trade Commission about his dealings in 2006 with Canadian generic drugmaker Apotex Inc.
Story in NY Times.
Wonder when the New York Times will write about the criminal indictments against Pfizer execs and their Bextra related off-label crimes?
Monday, April 06, 2009
The “information” document filed by federal prosecutors against Mary Holloway describes what appears to be a rogue sales unit inside Pfizer dedicated to selling the painkiller Bextra off-label and at unapproved doses. Holloway is believed to be a former Pfizer employee (see Peter Rost’s join-the-dots conclusion) although documents in the case never explicitly state it.
Holloway is charged with marketing Bextra for uses and dosages that were not approved by the Food and Drug Administration. She has pled not guilty. She faces six months in prison if convicted.
The Holloway charges appear to be linked to those against ex-Pfizer exec Thomas Farina, who pled guilty to off-label Bextra selling in March.
Federal prosecutors allege an unusually brazen effort by Holloway to promote the drug, based extensively on lies. Among those alleged lies: Holloway asked that her sales reps not be told that the FDA had not approved Bextra for certain types of post-surgery pain; Holloway and her team promoted Bextra for unapproved uses, invented false safety claims, and invented false clinical claims such as that Bextra was safer than Vioxx. Holloway’s team even invented a fictional protocol for Bextra use in OB/GYN surgery pain, even though Bextra was not approved for such. Of course, the bogus protocol used Bextra at unapproved dosages.
Here’s a digest of the charges against her (you can download the entire document here).
The document starts by describing how the FDA informed Pfizer by letter that it was not approving Bextra for acute pain because of CV events in coronary bypass graft surgery:
Holloway received a copy of the FDA’s letter raising these concerns and forwarded it to other Pharmco managers. Holloway asked these managers not to share the FDA’s letter with the sales representatives.
(”Pharmco” is the euphemism the feds use for Pfizer. See an explanation of this below.)
Holloway promoted and caused the promotion of the sale and use of Bextra for a variety of uses and at dosages other than the Approved Uses and Dosages, …
Holloway and those acting at her direction routinely did not disclose that the FDA had specifically declined to approve Bextra as safe and effective for these uses.
Holloway also caused her sales force to promote Bextra with false claims of safety, including that Bextra had no dose proportional increase in hypertension and edema, that Bextra had no cardiovascular risks and that Bextra had placebo-like side effects.
Holloway also caused sales representatives to promote Bextra by telling physicians that Bextra was safer and more effective than Vioxx, despite the fact that there was no head-to-head studies of Bextra and Vioxx for the approved uses of Bextra that showed that Bextra was safer or more effective.
… a sales representative working under Holloway in Massachusetts drafted and recommended a protocol for the unapproved use of Bextra to control pain in OB/GYB surgeries, including at unapproved dosages, to a physician in Massachusetts.
Holloway later praised this rep in an email for the “Fantastic protocol.”
Holloway instructed her sales team to claim that Bextra could be used before, during and after surgery to reduce the risk of Deep Vein Thrombosis or “DTVs,” a form of life-threatening blood clots that can form during or after surgery, even though she knew there were no studies of Bextra showing that it was safe or effective for this use.
She also instructed her sales force to send out unsolicited medical letters to Vioxx loyalists as if they had asked Pfizer a medical question.
Rost notes that Pfizer is not mentioned in the document, even though her name pops up as a Pfizer employee on both LinkedIn and Cafe Pharma. He claims that part of Pfizer’s $2.3 billion deal with the feds includes a promise that the feds will not name Pfizer in connection with off-label Bextra sales ever again. “Maybe this is what you get when you pay $2.3 billion to the government–the Pfizer name kept out of the press?” he says.
That’s probably exactly it. A $2.3 billion settlement is huge. BNET noted that Pfizer only revealed the settlement on the same day it acquired Wyeth; thus eclipsing the scandal. Further, Pfizer kept the settlement contingency out of its investor relations press releases even though they were included in its disclosures to the SEC.
Such massive settlements usually include language that bring the matter to a close. In order not to disrupt the settlement, the feds seem to have chosen to avoid mentioning Pfizer’s name in their ongoing mop-up of the individual clowns involved.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Email Jim Edwards Or
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Saturday, April 04, 2009
U.S. Department of Justice Press release on off-label conviction of Pfizer executive makes sure the Pfizer name is not mentioned.
Maybe this is what you get when you pay $2.3 billion to the government--the Pfizer name kept out of the press?
FOR IMMEDIATE RELEASE
MARCH 30, 2009
CONTACT: CHRISTINA DiIORIO-STERLING
PHARMACEUTICAL COMPANY MANAGER PLEADS GUILTY TO OFF-LABEL MARKETING
BOSTON, MA - A Branchburg, NJ, woman agreed to plead guilty to violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.
United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim Rice, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office; and Drew Grimm, Special Agent in Charge of the U.S. Office of Personnel Management, Office of Inspector General - Eastern Operations, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has plead guilty to a one count Information charging her with distribution of a misbranded drug.
According to the Information from approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. The Information charges that, in 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra. Bextra was withdrawn from the market in April 2005.
HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.
HOLLOWAY faces up to six months’ imprisonment, to be followed by not more than 3 years of supervised release and a maximum fine of $100,000 or twice the amount of gross loss or gross gain.
The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the Food and Drug Administration, the Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, the Office of Inspector General for the United States Postal Service and the Office of Inspector General for the U.S. Office of Personnel Management. It is being prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Sullivan’s Health Care Fraud Unit.
Pfizer executive pleads guilty to distribution of a misbranded drug - Bextra. So why did a U.S. court hide the fact that the exec worked Pfizer?
It turns out the court documents don't list the Pfizer name--they call the company "Pharmco."
And the regular press haven't reported a word about this story in spite of the fact that this executive told "roughly 100 representatives under her supervision that they should promote a pain drug for uses she knew had been rejected by the Food and Drug Administration."
This is what Boston Business Journal wrote:
A former drug company sales executive pleaded guilty in Boston federal court to telling the roughly 100 representatives under her supervision that they should promote a pain drug for uses she knew had been rejected by the Food and Drug Administration.
Mary Holloway, who is 47 years old and lives in New Jersey, was a regional sales manager for a company listed in court documents as Pharmco. The drug she pleaded guilty to inappropriately selling carried the brand name Bextra. The painkiller has since been pulled from the market by Pfizer Inc. (NYSE:PFE), which had acquired its prior owner.
“Holloway was aware of the FDA's safety concerns, but...she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve,” U.S. Attorney Michael Sullivan's office wrote in a news release.
Holloway pleaded guilty to one count of distribution of a misbranded drug. Under federal guidelines, she could be sentenced to six months in prison and a fine of $100,000. But according to court documents, Sullivan's office agreed to recommend two years' probation and a $75,000 fine.
In recommending the reduced sentence, Sullivan's office cited Holloway's “prompt acceptance of personal responsibility...and information known to the U.S. attorney at this time.” The nature of that “information” is not disclosed.
Holloway's involvement with prosecutors dates at least to January 2006, court records indicate.
Court documents available Monday night don't suggest any injuries were linked to dosages prescribed by doctors who received inappropriate advice linked to Holloway.
Late last year, Massachusetts Attorney General Martha Coakley and counterparts in three dozen states entered into a civil settlement related to the marketing of Bextra and a related drug.
The investigation continues, Sullivan's office said.
So how do we know that Mary Holloway worked for Pfizer? Of course the fact that her LinkedIn page says she spent 18 years at Pfizer means she probably did.
We also do know that she was allegedly the boss of Thomas Farina from Pfizer, according to a comment on Pharmalot last year.
Thomas Farina, a former district sales manager at Pfizer, was found guilty of obstruction of justice, which was reported on March 19, 2009, after he was found altering documents on his computer during a federal investigation of off-label sales of Bextra and Celebrex. He faces a possible 20 years in prison and a $250,000 fine. He also allegedly instructed three of the reps he supervised to delete and alter incriminating documents on their computers. The verdict came in a criminal trial in federal court in Massachusetts.
Ms. Holloway was also identified as a Pfizer employee on Cafe Pharma back in 2007.
So . . . Pfizer sales execs are now starting to go to jail for the Bextra scandal which has resulted in Pfizer taking a $2.3 billion charge for off-label marketing, which Pfizer tried to hide by reporting this whopping amount the same day they reported they were going to buy Wyeth.
The only remaining questions are . . . who is next and why is a US Court assisting Pfizer's PR machine by hiding the Pfizer name when a Pfizer executive pleads guilty to a crime she committed as a Pfizer employee?
Did Pfizer negotiate a deal keeping their name hidden as part of the $2.3 billion settlement?